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US monitoring cloned animals for use as food

PostPosted: Sun Aug 06, 2006 11:46 am
by shyvet
WASHINGTON (Reuters) - U.S. regulators said Tuesday they have urged companies
that clone livestock to apply for U.S. permission before they put the animals'
meat or milk into the food supply.

The Food and Drug Administration (news - web sites) is developing policy
guidelines on whether cloned animals that are not genetically modified should be
tightly regulated like drugs. Officials are trying to determine whether the
animals present any safety risks.

The agency plans to issue its position after the National Academy of Sciences
(news - web sites) completes a report assessing if cloned animals pose any
hazards to animals, human health or the environment. The report is due out early
next year.

In the meantime, the FDA has advised a handful of companies that clone sheep,
cows or pigs to file an application with the agency if they want to sell cloned
animals as food. So far, none have indicated they want to do so in the near
term.

``If people insist on putting them into the food supply ... before the report is
out, we would recommend that they come into us with an investigational
application first, just to be on the safe side,'' said John Matheson, a senior
regulatory scientist at

the FDA's Center for Veterinary Medicine.

Companies involved in animal cloning include PPL Therapeutics, creator of Dolly
the sheep, Infigen Inc. and Advanced Cell Technology.

Scientists clone animals by taking DNA from an adult cell and placing it in a
female egg stripped of its own genetic material. The embryo is implanted into a
surrogate mother, and the baby animal is a clone.

Such cloned animals are genetic copies of another animal, and they do not pose
the same concerns as animals whose genes have been modified.

``In theory these animals should be fine, but we want to make sure there isn't
any risk associated with them,'' Matheson said.

At a congressional hearing in March, experts reported high rates of failures in
animal cloning attempts and birth defects as arguments against cloning people.

The FDA commissioned the National Academy study to help regulators decide
whether cloned animals should require ''pre-market'' approval, as drugs do, or
if they should be classified like in-vitro fertilization, which is more loosely
regulated.

``We're trying to make a science-based decision on whether unmodified cloned
livestock should be regulated on a pre-market approval basis,'' Matheson said.

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